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Application 202356
- Type
- NDA
- Sponsor
- PFIZER LABS
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 20MG/2ML (10MG/ML) | No | No |
| 002 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 80MG/8ML (10MG/ML) | No | No |
| 003 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 130MG/13ML (10MG/ML) | No | No |
| 004 | DOCETAXEL | DOCETAXEL | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 55749 | SUPPL | 2018-10-01 |
| 55621 | SUPPL | 2018-09-26 |
| 50498 | SUPPL | 2017-11-27 |
| 50482 | SUPPL | 2017-11-24 |
| 44855 | ORIG | 2015-02-06 |
| 22887 | ORIG | 2015-02-06 |
| 40174 | ORIG | 2014-03-19 |
| 10035 | ORIG | 2014-03-18 |